WHO has a regional office for Europe in
Copenhagen, WHO-Euro. At WHO-Euro
there is a special department for "Quality of
Care and Technologies". Our Board Member
Kirsten Staehr Johansen is chief of this de–
partment. She has very firm views on Quality
Assurance, and she wants to include cost
benefit aspects.
In principle I agree with her view, and
ECCLS has a contractual service agreement
with WHO-Europe according to which
ECCLS shall develop criteria for the rational
use of laboratory tests. A proposal for such a
committee was, however, postponed by the
Management Board in 1988.
There also exists an International Society
for Quality Assurance in Health Care.
Amongst its aims is to encourage the use of
standard terminology in QA and cost contain–
ment. The Association has announced a new
Journal called "Quality Assurance in Health
Care". The first issue was scheduled to appear
this spring.
Another organization engaged in health is
the Council of Europe with 23 member states
from Western Europe. Since 1974 the Council
has prepared a number of reports and adopted
four recommendations in the field of blood
transfusion, immunohematology and histo–
compatibility and also a booklet on quality
control in blood transfusion services, which is
updated every year.
CEN
Let me now tum to another faith and another
god, the God of the new Europeans i. e. CEN,
"Comite Europeen de Normalisation". CEN
and CENELEC are the European equivalents
to ISO and IEC. Both are non-govemmental
foundations with agreements with the Council
of European Communities ånd with EFTA.
The decision making body is composed of del–
egates from recognized national standardiza–
tion organizations, one from each of the 18
countries. The member countries are obliged
to implement CEN standards and to remove
Klinisk kemi
i
Norden
any national standards which are not compati–
ble with the CEN standards. The countries
have also agreed not to start any new stand–
ardization projects in an area in which CEN
has a standardization project. Formally CEN
standards are voluntary, but in reality they are
not.
CEN has recently become engaged in the
area of laboratory medicine. The background
is a proposal in 1987 from DIN, the German
Standardization Institute, that CEN should
establish a technical committee on laboratory
medicine. CEN established a technical com–
mittee, TC140 and accepted DIN's offer to be
in charge of the Technical seeretariat.
The TC140 bad a meeting in Berlin in Geto–
ber when the committee was renamed "In Vi–
tro Diagnostics". Dr Grassl from Boehringer–
Mannheim is now chairholder of the TC140
and the committee has started four Working
Groups, one on Good Manufacturing Prac–
tice, one on Labelling, one on Terminology,
couvened by Professor Verwilghen, and one
on Structure and Format of Description of
Reference Proeectures and Reference Materi–
als, couvened by Dr Dybkaer.
Since 1979 there is a European Diagnostic
Manufacturing Association, EDMA, which
takes care of the Industries' interests and co–
operates with CEN.
PROFESSIONAL SOCIETIES
Let me now tum to the specialist professional
societies. IFCC, the International Federation
for Clinical Chemistry, has three divisions,
one for education, one for publication and a
scientific division. The scientific division has
replaced the initial committee on standards
from 1966, whose work resulted in many rec–
ommendations on analytical nomenclature,
reference methods (reference procedures) and
qua1ity control. Presently the work includes
more subjects of interest both to clinicians
and clinical chemists such as Drug Interfer–
ences and Drug Effects, Theory of Reference
Values and Rational Use ofClinical Laborato-
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